A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00462345
First received: April 18, 2007
Last updated: October 7, 2013
Last verified: October 2013

April 18, 2007
October 7, 2013
June 2007
July 2009   (final data collection date for primary outcome measure)
Percentage of patients with ACR 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of patients with an ACR20 response at week 24.
Complete list of historical versions of study NCT00462345 on ClinicalTrials.gov Archive Site
  • ACR 50/70; change in DAS; EULAR response; changes in ACR core set; SF-36; radiographic analysis. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, immunology parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: ACR50/70 at week 24; DAS from baseline to week 24; EULAR response at week 24; changes in ACR core set; SF-36; radiographic analysis. Safety: AEs, lab parameters, immunology parameters.
Not Provided
Not Provided
 
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies

This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: rituximab [MabThera/Rituxan]
    1000mg iv on days 1 and 15
  • Drug: Methotrexate
    10-25mg po or parenteral/week
Experimental: 1
Interventions:
  • Drug: rituximab [MabThera/Rituxan]
  • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • rheumatoid arthritis for >=6 months;
  • receiving outpatient treatment;
  • an inadequate response to at least one anti-TNF therapy;
  • stable methotrexate for >=12 weeks.

Exclusion Criteria:

  • other rheumatic autoimmune disease or inflammatory joint disease;
  • previous treatment with MabThera;
  • concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00462345
ML20934
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP